Multistate outbreak of Pseudomonas fluorescens bloodstream infection after exposure to contaminated heparinized saline flush prepared by a compounding pharmacy.
BACKGROUND
Pharmaceutical compounding, the manipulation of ingredients to create a customized medication, is a widespread practice. In January 2005, the Centers for Disease Control and Prevention was notified of 4 cases of Pseudomonas fluorescens bacteremia that were traced to contaminated heparinized saline intravenous flush syringes prepared as a compounded medical product.


METHODS
We reviewed medical records of symptomatic patients with P. fluorescens-positive cultures of blood specimens or sections of explanted catheters, reviewed the production process of syringes, performed syringe cultures, compared isolates by pulsed-field gel electrophoresis (PFGE), and examined catheters by scanning electron microscopy.


RESULTS
We identified 80 patients in 6 states with P. fluorescens-positive cultures during December 2004-March 2006. Sixty-four patients (80%) had received a diagnosis of cancer. Seventy-four (99%) of 75 patients for whom information about catheter type was available had long-term indwelling catheters. Thirty-three (41%) of 80 cases were diagnosed 84-421 days after the patient's last potential exposure to a contaminated flush (delayed-onset cases). Compared with patients with early infection onset, more patients with delayed infection onset had venous ports (100% versus 50%; P <.001). By PFGE, clinical isolates from 50 (98%) of 51 patients were related to isolates cultured from unopened syringes. Scanning electron microscopy of explanted catheters revealed biofilms containing organisms morphologically consistent with P. fluorescens.


CONCLUSIONS
This outbreak underscores important challenges in ensuring the safety of compounded pharmaceuticals and demonstrates the potential for substantially delayed infections after exposures to contaminated infusates. Exposures to compounded products should be considered when investigating outbreaks. Patients exposed to contaminated infusates require careful follow-up, because infections can occur long after exposure.
Gershman
Mark D
MD
Epidemic Intelligence Service, National Center for Preparedness, Detection and Control of Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Kennedy
Donald J
DJ
Noble-Wang
Judith
J
Kim
Curi
C
Gullion
Jessica
J
Kacica
Marilyn
M
Jensen
Bette
B
Pascoe
Neil
N
Saiman
Lisa
L
McHale
Jean
J
Wilkins
Melinda
M
Schoonmaker-Bopp
Dianna
D
Clayton
Joshua
J
Arduino
Matthew
M
Srinivasan
Arjun
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016470:Bacteremia / Q000453:epidemiology* / Q000382:microbiology; D015373:Bacterial Typing Techniques; D001769:Blood / Q000382:microbiology; D002408:Catheters, Indwelling / Q000009:adverse effects* / Q000382:microbiology; D002648:Child; D002675:Child, Preschool; D003428:Cross Infection / Q000453:epidemiology* / Q000382:microbiology; D004196:Disease Outbreaks; D016521:Electrophoresis, Gel, Pulsed-Field; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008855:Microscopy, Electron, Scanning; D008875:Middle Aged; D011552:Pseudomonas Infections / Q000453:epidemiology* / Q000382:microbiology; D011551:Pseudomonas fluorescens / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D012965:Sodium Chloride / Q000009:adverse effects* / Q000627:therapeutic use
D012965:Sodium Chloride